The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Tightrail Rotating Dilator Sheath, Tightrail Mini Rotating Dilator Sheath.
| Device ID | K150360 |
| 510k Number | K150360 |
| Device Name: | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | SPECTRANETICS, INC. 9965 FEDERAL DRIVE Colorado Springs, CO 80921 |
| Contact | Christopher S Mclellan |
| Correspondent | Christopher S Mclellan SPECTRANETICS, INC. 9965 FEDERAL DRIVE Colorado Springs, CO 80921 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-12 |
| Decision Date | 2015-03-04 |
| Summary: | summary |